Engineering and manufacturing partner for complex in-vitro diagnostics, point-of-care and medical technology devices.
LRE Medical GmbH
Nördlingen · MunichNew on Amplifa
About LRE Medical
LRE Medical GmbH is an engineering and contract manufacturing partner (CDMO) for complex diagnostic, medical and life sciences devices. The company develops and produces point-of-care instruments, complex IVD analyzers and miniaturized optical modules – including electronics, mechanics, optics, software/firmware and systems engineering. Manufacturing includes in-house SMD assembly on its own line (SPI, inline AOI/AXI), PCB testing (Flying Probe, ICT, FCT), assembly of highly integrated devices in product-specific assembly cells, and precision assembly in cleanrooms of various classes. Production engineering based on GMP and LEAN principles, process validation, Six Sigma and complete traceability complement the service portfolio, along with supply chain management and order fulfillment. Customers include IVD manufacturers and biotech companies, such as QIAGEN, QuidelOrtho and deepull. The headquarters with production and logistics is located in Nördlingen; in Munich, product and systems development, EMC testing and a CNC center are based.
- Site
- Nördlingen
- Processes
- Product Development & Engineering (Electronics, Mechanics, Optics, Software, Firmware, Systems), Optics development (fluorescence, reflectance, absorption, spectrophotometry, luminescence, SPR),, In-house prototyping (model shop, 3-D printing), In-house SMD PCB assembly (SPI, inline AOI, inline AXI, in-circuit & functional testing), PCB test (Flying Probe / ICT / FCT, µC programming), integration & rework, Custom, highly integrated device assembly (product-oriented assembly cells, module and end-of-line, Highly precise miniaturised production (e.g. optical modules) in cleanroom environments of various, Production engineering (process design GMP/LEAN, jigs, tools, fixtures, functional test
- Materials
- SMD/PCB Assembly, Cleanroom Assembly, Optics Manufacturing/Assembly, EMC Testing, CNC Machining, 3D Printing / Model Shop
- Certificates
- EN ISO 13485:2016, ISO 9001, EN ISO 13485, FDA Registration, GMP Compliance
- Founded
- 1961
- Employees
- 235+
- Industries
- In-Vitro Diagnostics (IVD), Point-of-Care Diagnostics, Medical Technology, Life Sciences / Analytics, Biotech
- 01
Product Development & Engineering (Electronics, Mechanics, Optics,
- 02
Prototyping (Model Shop, 3D Printing, Flow Boxes)
- 03
Production Engineering & Process Design (GMP, LEAN, Six Sigma)
- 04
SMD Assembly & PCB Test (SPI, AOI/AXI, FP/ICT/FCT)
- 05
Device Assembly & Module/End-of-Line Testing (incl. Cleanroom)
- 06
Supply Chain Management & Order Fulfillment
- 07
Quality & Regulatory Support
- 08
Lifecycle Management & After-Sales Service
Manufacturing Processes & Technology
SMD/PCB Assembly
Own high-speed SMD line for flexible, regulated electronics production with 100% inline inspection.
Cleanroom Assembly
Assembly of sensitive components such as optical modules in cleanrooms of various classes.
Optics Manufacturing/Assembly
Miniaturized optical modules for fluorescence, spectrophotometry and SPR detection.
EMC Testing
Orienting EMC testing in an own measurement chamber in Munich.
CNC Machining
CNC center in Munich for mechanical components and prototyping.
3D Printing / Model Shop
In-house rapid prototyping of mechanical parts and housings.
Locations
Nördlingen
DEHeadquarters, Production, Logistics
- Lot size
- High-Mix / Low-Volume
- Materials
- Electronics, Optics, Mechanics
- SMD assembly line (5,380 sq ft SMD area)
- Inline AOI/AXI incl. SPI
- Flying Probe / ICT / FCT
- Cleanrooms of various classes
- Product-specific assembly cells
Munich
DEProduct and Systems Development, EMC Testing, CNC Center
- Lot size
- Prototype, Small Series
- EMC measurement chamber
- CNC center
- Flow boxes for optics prototyping
- 3D printing / model shop
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Product Development & Engineering (Electronics, Mechanics, Optics, Software, Firmware, Systems)Engineering | – | – | – | – | – |
| Optics development (fluorescence, reflectance, absorption, spectrophotometry, luminescence, SPR),Engineering | – | – | – | – | – |
| In-house prototyping (model shop, 3-D printing)Additive | – | – | – | – | – |
| In-house SMD PCB assembly (SPI, inline AOI, inline AXI, in-circuit & functional testing)Assembly | – | – | – | high-mix / low-volume | – |
| PCB test (Flying Probe / ICT / FCT, µC programming), integration & reworkTesting | – | – | – | – | – |
| Custom, highly integrated device assembly (product-oriented assembly cells, module and end-of-lineAssembly | – | – | – | – | – |
| Highly precise miniaturised production (e.g. optical modules) in cleanroom environments of variousAssembly | – | – | – | – | – |
| Production engineering (process design GMP/LEAN, jigs, tools, fixtures, functional testEngineering | – | – | – | – | – |
| Quality & Regulatory Support (ISO 13485, FDA 21 CFR 820, MDR/IVDR, ISO 14971, IEC 62304)Testing | – | – | – | – | – |
| Lifecycle Management & After-Sales Service (sustaining engineering, in-house repair, refurbishment,Engineering | – | – | – | – | – |
| Supply Chain Management & Order Fulfillment (strategic purchasing, material planning, tradeAssembly | – | – | – | – | – |
| EMC testing (in-house orienting test in EMC chamber)Testing | – | – | – | – | – |
7 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| SMD assembly line (dedicated 5,380 sq ft area, high-speed flexible PCB production) | – | – | 5,380 sq ft dedicated SMD assembly area | – | Noerdlingen |
| Inline AOI / AXI inspection systems (incl. SPI) | – | – | – | – | Noerdlingen |
| EMC testing chamber | – | – | – | 2019-2020 | Munich |
| CNC center | – | – | – | 2019-2020 | Munich |
| Cleanroom environments of various classifications for assembly of sensitive components (e.g. optics) | – | – | – | – | Noerdlingen |
| Flow boxes (in-house optics prototyping) | – | – | – | – | – |
| 3-D printing / model shop | – | – | – | – | – |
Additional services
Reference customers
Quality & Certifications
The quality management system is certified according to EN ISO 13485:2016, the company is FDA-registered and, upon request, complies with FDA 21 CFR Part 820, MDR/IVDR and GMP requirements. All production processes are linked with 100% component traceability, batch inspection, CoC-based release, CAPA and risk management (ISO 14971).
| Evidence | Nördlingen |
|---|---|
| ISO 9001 | |
| EN ISO 13485 | |
| FDA Registration | |
| GMP Compliance |
History
- 1961
Founding of Leach Relais und Elektronik GmbH in Munich for the production of relays for aerospace applications.
- 1969
Start of the production site in Nördlingen.
- 1970
Entry into medical technology: development of the world's first blood glucose meter for home monitoring.
- 1974
Expansion of development and manufacturing competencies for Home Care and Near-Patient Testing.
- 2019
Acquisition by KPS Capital; establishment of EMC testing and CNC center in Munich; production ramp-up of a fully automated test system for SARS-CoV-2 rapid diagnostics.
- 2021
Acquisition by Gyrus Capital S.A.; development of a walk-away laboratory automation system.
- 2022
Development of a fully automated sample preparation device.